MAUDE Adverse Event Report: COMPASS HEALTH BRANDS CAREX; UPLIFT COMMODE ASSIST

Model Number CCFCA200

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

Event Description

The seat came off the rails in the back and the end-user almost fell.Upon inspection by the end-user it looked like the connection for the rail on the right side broke off of the crossbar.

• Brand Name: CAREX
• Type of Device: UPLIFT COMMODE ASSIST
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights,
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights,
• Manufacturer Contact: cynthia toney ; 6753 engle road; middleburg heights, ; 2682110
• MDR Report Key: 9717002
• MDR Text Key: 193394376
• Report Number: 3012316249-2020-00008
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CCFCA200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1